AM vs PM Exercise Training

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Behavioral: 6 weeks of exercise training (Pre-training); Behavioral: 6 weeks of exercise training (Post-training)

• Registration Number: NCT06042439
• Lead Sponsor: Michigan State University

Brief Summary

The treatment of high blood pressure, or hypertension, is multifaceted and can include pharmacological therapies (i.e., medications) and lifestyle modifications such as physical activity. Chronotherapy, which describes timing of a treatment with the body's daily rhythms, has recently been used with hypertension medications and has been shown to be effective at lowering blood pressure and reducing the risk of cardiovascular disease events. Specifically, taking medications in the evening was shown to be more effective than morning medication routines. Little information is available about the effectiveness of chronotherapy combined with exercise (i.e., planned physical activity) interventions in older adults with hypertension. The purpose of this study is to examine how exercise training performed in the morning and early evening affects blood pressure and other measures of blood vessel health in postmenopausal females with hypertension.

Detailed Description

Blood pressure has an internal rhythm associated with the 24-hr clock. Nocturnal blood pressure (BP) is a key contributor to cardiovascular health and may be improved by exercise. Moreover, the time of day of the exercise may be a key factor. This study aims to evaluate the effects of morning and evening exercise training on BP and other measures of vascular function in older females with hypertension.

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-18
• Status Verified: 2024-06
• Study Start: 2024-06-11
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2026-06-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 79

Inclusion Criteria

• Systolic BP equal to or greater than 130 mmHg without BP medication or greater than 120 mmHg with medication and diastolic blood pressure equal to and greater than 80 mmHg
• 55-80 years old
• Post-menopausal female
• Able to walk without assistance

Exclusion Criteria

• Habitually physically active defined as 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week
• Overt pulmonary disease/condition as follows: chronic bronchitis, chronic obstructive pulmonary disease, emphysema, or pulmonary hypertension
• Cardiometabolic disease/condition as follows: diabetes, heart failure, peripheral arterial disease, stroke, coronary artery disease, renal disease, secondary hypertension, chronic venous insufficiency or deep vein thrombosis within last 6 months
• Cancer within last 5 years
• Body mass index >39 kg/m2
• Current smoking or vape
• Evening shift work
• uncontrolled thyroid disorder
• 2 or more falls in the last year
• Anemia within 3 months of enrollment
• Parkinson's disease
• Dementia
• Unstable angina
• Acute pulmonary embolus or infarction
• Acute myocarditis or pericarditis
• Acute aortic dissection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Morning (AM)	6 weeks of exercise training (Pre-training)	Exercise starting before 10:01 AM
Evening (PM)	6 weeks of exercise training (Post-training)	Exercise starting after 3:59 PM
Morning (AM)	6 weeks of exercise training (Post-training)	Exercise starting before 10:01 AM
Evening (PM)	6 weeks of exercise training (Pre-training)	Exercise starting after 3:59 PM

Primary Outcome Measures

Name	Time	Method
Nocturnal systolic blood pressure (BP)	6 weeks	Change in systolic nocturnal BP (Pre-training - Post-training)

Secondary Outcome Measures

Name	Time	Method
Endothelial function	6 weeks	Change in flow mediated dilation of the brachial artery (Post-training - Pre-training)
Microvascular function	6 weeks	Change in rapid onset vasodilation of the popliteal artery
Ambulatory blood pressure	6 weeks	Change in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)
Arterial stiffness	6 weeks	Change in carotid femoral pulse wave velocity (Pre-training - Post-training)

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States